Ardis. Surgical Technique. Interbody System. Solutions by the people of Zimmer Spine. zimmerspine.com

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1 Ardis Interbody System Surgical Technique Solutions by the people of Zimmer Spine. zimmerspine.com

2 A more advanced interbody solution. From the people of Zimmer Spine. The easily inserted Ardis Interbody System facilitates an efficient, reproducible fusion procedure with a self-distracting nose, convex geometry and wide range of sizes. This unique interbody system is designed for versatility and it can be used in a variety of open or MIS surgical applications. The Ardis System comes complete with best-in-class instrumentation and is backed by the training, service and expertise that surgeons have come to expect from Zimmer Spine. A variety of options to fit your needs and your patient s anatomy. A complete MIS solution. The Ardis System can be used as part of Zimmer Spine s industry-leading MIS portfolio. Minimally invasive procedures deliver less operative trauma to the patient when compared to open procedures. The benefits of this approach can include less pain and scarring, reduced operating time, accelerated patient recovery and minimized hospital stays. Zimmer Spine offers a complete MIS solution with best-in-class devices for disc preparation, access and fixation.

3 Table of Contents Description/Indications/Contraindications 1 Ardis Implants 3 Harmony Posterior Instruments 4 Ardis Instruments 5 Surgical Technique 7 Kit Contents 17 Warnings and Precautions 21

4 Description/Indications/Contraindications Description The Ardis implant is a device for interbody fusion of the anterior column of the spine. Ardis may be used to replace the disc. These cages are hollow so that bone can grow through the device, fusing the adjacent bony surfaces. The Ardis implant is a hollow device with texture on two opposing convex sides, and is offered in various lengths, widths and heights. Zimmer Spine designed the Ardis device to be placed through a posterior or transforaminal approach and to address vertebrae in the lumbosacral region of the spine. The system contains implants of various sizes to accommodate different patient anatomy, and instruments for site preparation, trialing, insertion and extraction. The device is crafted from (polyetheretherketone) PEEK-OPTIMA (ASTM F2026). As PEEK-OPTIMA is radiolucent, radiographic markers are included in the distal and proximal ends of the PEEK implants. The markers consist of tantalum wires and beads (ASTM F560) that are press-fit into small holes in the implant. The Ardis instrumentation system is comprised of instruments and perforated instrument cases that are generally comprised of aluminum, stainless steel, and/or polymeric materials. Indications The Ardis Spacer is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment. The Ardis Spacer is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation. 1

5 Contraindications 1. Disease conditions which have been shown to be safely and predictably managed without the use of internal fixation devices are relative contraindications to the use of these devices. 2. Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation. 3. Severe osteoporosis is a relative contraindication because it may prevent adequate fixation of spinal anchors and thus preclude the use of this or any other posterior spinal instrumentation system. 4. Any entity or condition that totally precludes the possibility of fusion, i.e. cancer, kidney dialysis or osteopenia, is a relative contraindication. Other relative contraindications include obesity, pregnancy, certain degenerative disease, and foreign body sensitivity. In addition, the patient s occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, some patients may, because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism or drug abuse, place undue stresses on the implant. 5. Known patient sensitivity to device materials (PEEK-OPTIMA). 6. Prior fusion at the level(s) to be treated. 7. Any condition not described in the indications for use. 2

6 Ardis Implants The Ardis System s uniquely tapered nose minimizes insertion forces and provides an easy, atraumatic insertion. The device may be placed obliquely across the disc space, enabling highly efficient procedures that reduce time in the operating room. The Ardis System comes in 48 sizes, making it one of the most versatile interbodies in the industry. With this wide range of options, surgeons can ensure a customized fit to patient anatomy and can use the implant in a variety of surgical approaches. Length Height Width Ardis Implant 3201-series Height 9mm Width Implant 8mm 9mm 10mm 11mm 12mm 13mm 14mm 16mm Length Length 22mm X X X X X X X X 26mm X X X X X X X X 30mm X X X X X X X X Height 11mm Width Implant 8mm 9mm 10mm 11mm 12mm 13mm 14mm 16mm 26mm X X X X X X X X 30mm X X X X X X X X 34mm X X X X X X X X Height x Width Trial Sizes 8x 9mm 8x 11mm 9x 9mm 9x 11mm 10x 9mm 10x 11mm 11x 9mm 11x 11mm Length 22mm X X X X 26mm X X X X X X X X 30mm X X X X X X X X 34mm X X X X Height x Width Trial Sizes 12x 9mm 12x 11mm 13x 9mm 13x 11mm 14x 9mm 14x 11mm 16x 9mm 16x 11mm Length 22mm X X X X 26mm X X X X X X X X 30mm X X X X X X X X 34mm X X X X 3

7 Harmony Posterior Instruments Smooth Distractors (6-15mm) to Incrementally distract the disc space. Cutting Distractors (6-15mm) to Incrementally distract the disc space and shave vertebral endplates. Kerrison Rongeurs (2-4mm) series, series Cut boney structures and remove disc material. Feature bayoneted shaft and reduced glare finish. Pituitary Rongeurs (2-4mm) series, series Cut boney structures and remove disc material. Feature bayoneted shaft and reduced glare finish. Curettes , 2752-series, 2753-series, , 2851-series Prepare vertebral body endplates and remove disc material. Feature bayoneted shaft and reduced glare finish. Curettes available: Straight, Right, Left, Up-biting, Down-biting, Ring and O Brien. 4

8 Ardis Instruments The Ardis System s low-profile instrumentation is designed to improve visibility and precision. Each instrument has a glare-resistant coating and lengths that are conducive to both MIS and open procedures. Shavers (6-16mm) to Incrementally distract the disc space and shave vertebral endplates. Rasp, Straight Prepares vertebral body endplates by clearing cartilage and creating bleeding bone. Rasp, Curved Prepares vertebral body endplates by clearing cartilage and creating bleeding bone. Ardis Trials 3254-series Bullet-nosed trials in 48 sizes are utilized to estimate Ardis implant fit. 9mm Ardis Inserter Inserts the 9mm implant into the disc space. Threads into the implant s posterior hole. 11mm Ardis Inserter Inserts the 11mm width implant into the disc space. Threads into the implant's posterior hole. 5

9 Ardis Straight Tamp Advances the implant into its final position. Ardis Angled Tamp Advances the implant into its final position. Ardis Threaded Extractor Slaphammer Removes the implant if the Inserter cannot be reattached. This instrument has aggressive threads that will deform the implant s threaded connection. A new implant should be used if the first implant is explanted. Provides additional force in removal of Trials, Inserter or Extractor (if needed). T-Handle, 1/4" Square Drive Bone Funnel Attaches to Shavers for controlled insertion, removal and rotation. Bone Tamp Used to pack autograft material into disc space or implant. 6

10 Surgical Technique Preparation and Access Step 1 Patient Positioning Position on radiolucent table with adequate clearance for a fluoroscopic C-arm (for A/P, lateral and oblique images of pedicle and vertebral body). All other hardware utilized for patient positioning should be checked for radiolucency. Step 2 Pedicle Targeting Obtain A/P, lateral images of the affected level. Begin Harmony Surgical Port placement, accessing the facet with a Targeting Needle and K-wire. 7

11 Step 3 Sequential Dilation Sequentially slide Dilators #1 6 over K-wire; slide matching Depth Gauge over largest dilator, flange positioned distally. Note: Depth Gauges may be used as pushers to advance dilators through the musculature. Step 4 Port Measurement Rest the flange against the skin, locating the proximal end of Dilator #4, 5 or 6 in the Depth Gauge window. Identify the necessary Harmony Port length, referencing the measurements on the side of the Depth Gauge and rounding up. The #4 Dilator correlates to a 19mm port, the #5 Dilator correlates to a 22mm port and the #6 Dilator correlates a 26mm port. 8

12 Step 5 Port Placement Remove the port from its sterile package, slide over the dilator and dock it on the facet. Adjust the angle by wanding the dilators. Attach port to Snake Arm or Surgical Assist Mechanism (SAM) arm. Disc Space Preparation Step 6 Boney Decompression Using osteotomes and Kerrison Rongeurs, remove the facet and portions of the lamina. 9

13 Step 7 Ligamentum Flavum Cut ligamentum flavum from inferior portion of lamina. Mobilize with Woodson or Fine Curettes. Control epidural bleeding with cautery, avoiding contact with the Harmony Port or other instruments. Step 8 Nerve Root, Dura Mobilization Free the nerve root and dura from soft tissue; probe boney structures with a Ball Probe. Retract the nerve root and dura. 10

14 Step 9 Annular Window Remove blood and small tissue fragments with a suction catheter; create an annular window with an annulus knife. Step 10 Remove Disc Tissue Connect the Harmony Posterior Cutting Distractor or Ardis Shaver to its respective T-Handle and insert into the disc space; rotate it to free disc tissue. Remove disc fragments with Pituitary Rongeurs. Note: The distance from the tip to the laser-marked line on the Ardis Shaver indicates the approximate length of a 26mm implant. The distance from its tip to the point where the gold stops indicates the approximate length of a 34mm implant. 11

15 Step 11 Endplate Preparation With osteotomes, remove osteophytes and the posterior lip of adjacent vertebral bodies. Remove remaining endplate cartilage with curettes or the Ardis Straight or Angled Rasps. Make sure the endplates are well cleaned to create a surface of bleeding bone. Sizing and Placement Step 12 Distraction With progressively sized Harmony Smooth Distractors, Harmony Cutting Distractors or Ardis Shavers, open the disc space to the desired height. Connect a Distractor or Shaver to its respective T-Handle. Insert into the disc space and rotate its axis, opening the space to a height equal to the Distractor. Note: The distance from the tip to the laser-marked line on the Ardis Shaver indicates the length of a 26mm implant. The distance from its tip to the point where the gold stops indicates the length of a 34mm implant. 12

16 Step 13 Implant Sizing Insert an Ardis Trial into the disc space and view under fluoro to determine the proper implant size. The Slaphammer can be used to remove the Ardis Trial, if necessary. Note: TLIF approach shown. PLIF approach also possible. Step 14 Final Implant Preparation Select the implant size based on the Ardis Trial s fit. There is no need to undersize or oversize the implant. With the Bone Tamp, pack the implant with graft material. Select the appropriate Ardis Inserter based off of the width of the selected implant. Use the 9mm Ardis Inserter for a 9mm implant and the 11mm Ardis Inserter for an 11mm implant. Attach the implant to the inserter by advancing the threaded distal tip of the inserter into the implant's posterior hole. This is accomplished by turning the knob clockwise until it is fingertight. If it is difficult to thread, loosen the knob, detach and reattach the implant to prevent cross-threading. Use caution not to overtighten the implant. Note: Do not use the 11mm Ardis Inserter with the 9mm implant. When the correct implant is attached to the correct inserter, the posterior end of the implant will be flush against the inserter. The 11mm implant will not engage with the 9mm Ardis Inserter. 13

17 Step 15 Implant Insertion Insert the implant into the disc space. A mallet can be used for insertion. When malleting, take caution to avoid excessive impaction force and ensure malleting occurs on-axis. Additionally, avoid the application of torque to the Ardis Inserter handle. Confirm position radiographically and detach the implant from the Inserter by turning the knob counterclockwise until the threaded portion disengages from the implant's posterior threaded hole. Note: The Ardis System is not designed to be inserted on its side and be rotated into position. Note: If difficulty loosening the knob is encountered, the Ardis Bone Tamp may be used to loosen the knob by engaging it with one of the four holes in the Ardis Inserter knob. The bone tamp should not be used to assist in tightening of the knob. Maintain on-axis alignment between Inserter and implants. Note: If difficulty loosening the knob is encountered, the Ardis Bone Tamp may be used to loosen the knob by engaging it with one of the four holes in the Ardis Inserter knob. The bone tamp should not be used to assist in tightening of the knob. 14

18 Step 16 Final Positioning Mate either the Straight or Angled Tamp onto the posterior portion of implant. Mallet the Tamp to drive the implant in the desired direction. Note: If using the Angled Tamp, make sure that the center nub is engaged in the posterior hole of the implant. Note: If an implant needs to be removed from the disc space, either attempt to reengage the Inserter or thread the Extractor into the posterior threaded hole at the end of the implant. The Extractor should not be inserted at a severe angle. Engage the Extractor perpendicular to the posterior end of the implant. The Slaphammer can be used. A new implant should be implanted. The Extractor should not be used for implant insertion. Step 17 Position Confirmation Confirm position radiographically. Use the Bone Funnel/Bone Tamp to pack autogenous graft material into the disc space around the implant. 15

19 Compression Option Step 18 Implant Compression (If Necessary) Insert rods into the pedicle screw construct, completing its assembly. Using the Compressor from the pedicle screw system kit, apply a load to the Ardis implant and lock the construct. Removal and Revision Implant Removal or Revision Should removal or revision of the implant be determined necessary early on post index procedure, it may still be possible to remove the implant via the original approach. The Extractor can be used to thread into the posterior end of the implant and be removed. The Slaphammer can be used if necessary. Once the healing process has begun, the surgeon may need to consider alternative approaches such as direct anterior or lateral. An osteotome can be used at the interface between the bone and both the superior and inferior faces of the implant to disengage the construct. This effectively cuts the fused column of bone at the level of the interface. Once the implant has been disengaged, the implant can be removed. Distraction can be used to allow easier access to the interface. Intraoperative Implant Removal Should removal of the device be required during surgery, the Inserter may be used to reengage the implant or the Extractor can be used. If the Extractor is used, engage the instrument with the threaded posterior hole of the Ardis implant and turn the handle clockwise until the threads bite into the PEEK material and the instrument is fully seated. Connect the Slaphammer to the proximal end of the Inserter to remove the implant. Distraction will allow for easier removal of the implant. Note: Once the implant is removed, it should not be reinserted and a new implant should be used. 16

20 Kit Contents Module Number PL Ardis Implant Module Part Number Description Standard Kit Quantity Ardis PEEK Implant 08x09x Ardis PEEK Implant 08x09x Ardis PEEK Implant 08x09x Ardis PEEK Implant 08x11x Ardis PEEK Implant 08x11x Ardis PEEK Implant 08x11x Ardis PEEK Implant 10x09x Ardis PEEK Implant 10x09x Ardis PEEK Implant 10x09x Ardis PEEK Implant 10x11x Ardis PEEK Implant 10x11x Ardis PEEK Implant 10x11x Ardis PEEK Implant 12x09x Ardis PEEK Implant 12x09x Ardis PEEK Implant 12x09x Ardis PEEK Implant 12x11x Ardis PEEK Implant 12x11x Ardis PEEK Implant 12x11x Ardis PEEK Implant 14x09x Ardis PEEK Implant 14x09x Ardis PEEK Implant 14x09x Ardis PEEK Implant 14x11x Ardis PEEK Implant 14x11x Ardis PEEK Implant 14x11x Ardis PEEK Implant 16x09x Ardis PEEK Implant 16x09x Ardis PEEK Implant 16x09x Ardis PEEK Implant 16x11x Ardis PEEK Implant 16x11x Ardis PEEK Implant 16x11x

21 Module Number PL Ardis Instrument Module Part Number Description Standard Kit Quantity Rasp, Straight Rasp, Curved Ardis Straight Tamp Ardis Angled Tamp Ardis Threaded Extractor Ardis Inserter, 9mm Ardis Inserter, 11mm Bone Funnel Bone Tamp Slaphammer T-handle, 1/4" Square Drive Shaver, 06mm Shaver, 07mm Shaver, 08mm Shaver, 09mm Shaver, 10mm Shaver, 11mm Shaver, 12mm Shaver, 13mm Shaver, 14mm Shaver, 15mm Shaver, 16mm Ardis Trial 08x09x Ardis Trial 08x09x Ardis Trial 08x09x Ardis Trial 08x11x Ardis Trial 08x11x Ardis Trial 08x11x Ardis Trial 09x09x Ardis Trial 09x09x Ardis Trial 09x09x Ardis Trial 09x11x Ardis Trial 09x11x Ardis Trial 09x11x Ardis Trial 10x09x Ardis Trial 10x09x

22 Module Number PL Ardis Instrument Module (Continued) Part Number Description Standard Kit Quantity Ardis Trial 10x09x Ardis Trial 10x11x Ardis Trial 10x11x Ardis Trial 10x11x Ardis Trial 11x09x Ardis Trial 11x09x Ardis Trial 11x09x Ardis Trial 11x11x Ardis Trial 11x11x Ardis Trial 11x11x Ardis Trial 12x09x Ardis Trial 12x09x Ardis Trial 12x09x Ardis Trial 12x11x Ardis Trial 12x11x Ardis Trial 12x11x Ardis Trial 13x09x Ardis Trial 13x09x Ardis Trial 13x09x Ardis Trial 13x09x Ardis Trial 13x11x Ardis Trial 13x11x Ardis Trial 14x09x Ardis Trial 14x09x Ardis Trial 14x09x Ardis Trial 14x11x Ardis Trial 14x11x Ardis Trial 14x11x Ardis Trial 16x09x Ardis Trial 16x09x Ardis Trial 16x09x Ardis Trial 16x11x Ardis Trial 16x11x Ardis Trial 16x11x Ardis Trials Outer Base Ardis General Outer Base 1 19

23 Module Number PL Ardis Instrument Module (Continued) Part Number Description Standard Kit Quantity Ardis Shaver Insert Tray Ardis 22 Trial Insert Tray Ardis 26 Trial Insert Tray Ardis 30 Trial Insert Tray Ardis 34 Trial Insert Tray Generic Stackable Lid 2 20

24 Warnings and Precautions Warnings Following are specific warnings, precautions, and adverse effects, which should be understood by the surgeon and explained to the patients. These warnings do not include all adverse effects, which can occur with surgery in general, but are important considerations particular to metallic internal fixation devices. General surgical risks should be explained to the patient prior to surgery. 1. Potential risks identified with the use of this device system, which may require additional surgery, include: a) Device component fracture. b) Loss of fixation. c) Non-union. d) Fracture of the vertebra. e) Neurological injury. f) Vascular or visceral injury. 2. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. The potential for satisfactory fixation is increased by the selection of the proper size, shape and design of the implant. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size, shape, and strength of implants. Use of provided trials is recommended. 3. IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION OR NON-UNION. Internal fixation appliances are load sharing devices which are used to obtain an alignment until normal healing occurs. If healing is delayed or does not occur, the implant may eventually break due to fatigue. The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant. Notches, scratches or bending of the implant during the course of surgery may also contribute to early failure. Patients should be fully informed of the risks of implant failure. 21

25 4. PATIENT SELECTION. In selecting patients for internal fixation devices, the following factors can be of extreme importance to the eventual success of the procedure: a) The patient s weight. An overweight or obese patient can produce loads on the device that can lead to a loss of interbody height or failure of the device and/or the operation. b) The patient s occupation or activity. If the patient is involved in an occupation or activity that includes substantial walking, running, lifting or muscle strain, the resultant forces can cause loss of disc height and/or failure of the device. c) A condition of senility, mental illness, alcoholism, or drug abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the appliance, leading to implant failure or other complications. d) Certain degenerative diseases. In some cases, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance. For such cases, orthopaedic devices can only be considered a delaying technique or temporary relief. e) Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made prior to material selection or implantation. f) Smoking. Patients who smoke have been observed to experience higher rates of pseudarthrosis following surgical procedures where bone graft is used. 5. These warnings do not include all adverse effects that can occur with surgery in general. General surgical risks should be explained to the patients prior to surgery. 6. Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery. 22

26 Precautions 1. Prior to use, the physician should be trained in the surgical procedure recommended for the use of this device. 2. The Ardis Device is a single use device and should not be reused. An explanted device should never be reimplanted. Possible risks associated with re-use of single use devices include: Mechanical Malfunction Transmission of infectious agents 3. The DEVICE has not been evaluated for safety and compatibility in the MR environment. The DEVICE has not been tested for heating or migration in the MR environment. Instruments Warnings and Precautions 1. Instruments must be thoroughly cleaned prior to sterilization. Instruments that are not clean may not be effectively sterilized. 2. Automated cleaning may not be effective. A thorough, manual cleaning process is recommended. 3. When handling sharp instruments, use extreme caution to avoid injury. 4. Unless otherwise indicated, instrument sets are provided non-sterile and must be sterilized prior to use. 5. Do not reuse instruments labeled for single use only. Reuse may adversely affect performance of the instrument. 6. Flash autoclaving should be avoided whenever possible. Instruments should never be flash autoclaved in an instrument case. 23

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28 Solutions by the people of Zimmer Spine. You are devoted to helping your patients reduce their pain and improve their lives. And the people of Zimmer Spine are devoted to you. We are dedicated to supporting you with best-in-class tools, instruments and implants. We are driven by the opportunity to share our unrivaled education and training. We are committed partners who will do everything in our power to assist you in your quest to provide the absolute best in spinal care. And we can be counted on always to act with integrity as ethical partners who are worthy of your trust. We are the people of Zimmer Spine. Disclaimer: This documentation is intended exclusively for physicians and is not intended for laypersons. Information on the products and procedures contained in this document is of a general nature and does not represent and does not constitute medical advice or recommendations. Because this information does not purport to constitute any diagnostic or therapeutic statement with regard to any individual medical case, each patient must be examined and advised individually, and this document does not replace the need for such examination and/or advice in whole or in part. Please refer to the package inserts for important product information, including, but not limited to, indications, contraindications, warnings, precautions, and adverse effects. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Please see the product Instructions for Use for a complete listing of the indications, contraindications, warnings, precautions and adverse effects. Manufactured by: Zimmer Spine 7375 Bush Lake Road Minneapolis, MN Zimmer Limited SN3 4FP, U.K zimmerspine.com PEEK-OPTIMA Polymer is a registered trademark of Invibio Ltd. L1467 Rev. D (07/13) (851S ) 2013 Zimmer Spine, Inc.